Specialist-I, QC Chem

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary of responsibilities

The Specialist-I, QC Chem role at Baxter Healthcare Corporation offers an outstanding opportunity to work within a world-class team, driving innovation and excellence in quality control. You will support the execution of the Validation Master Plan and Change Control associated with Data Integrity for the Alliston facility. This position involves preparing, executing, and detailing data integrity computer system validation protocols in strict accordance with Corporate Quality Policies, Health Canada, and ISO requirements. You will manage the installation and qualification of diverse laboratory equipment/software, collaborating with a diverse team to achieve maximum results in minimum time.

General expectations

The top two priorities for all Baxter Alliston employees are Safety and Quality:

Safety: Support our goal to achieve a “Zero Harm Environment” by ensuring the safety of yourself and your co-workers through:

Following all safety procedures

Understanding potential hazards in your area

Wearing appropriate PPE

Reporting all incidents/near-misses/concerns

Embracing 6s

Quality: Ensure the quality of our products to guarantee patient safety and achieve our mission of “Saving and Sustaining Lives.” This can be achieved through:

Following Good Manufacturing Practices (GMP)

Adhering to all quality procedures

Completing training timely

Doing it Right the First Time, and

Reporting any quality concerns immediately

As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:

Participating in improvement activities

Identifying and implementing continuous improvement ideas

Participating in Tier meetings

Recognizing your peers, and

Embracing 6s

Identifying and implementing VIP’s (Value Improvement Projects)

Embracing continuous learning

Applying Leader Standard Work

Using Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results

Essential duties and responsibilities

Time Spent

Major Responsibilities / Activities

80%

Design IQ/OQ/PQ and validation campaigns as well as develop, prepare, and write the protocols for equipment/software validation

Coordinate validation and IQ/OQ/PQ activities among Quality Control Laboratories and outside contractors, providing leadership, training, and mentorship

Monitor and support the execution of the protocols through training, facilitating, and problem-solving activities

Perform retrospective validation packages as required for legacy systems and processes

Prepare or assist in the preparation of Validation Maintenance packages

15%

Provide support for the Quality technical review/approval of department-related procedural changes and validations/protocols

Stay current with respect to regulatory trends and divisional issues related to their area of expertise

Partner with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives

5%

Complete requested month-end summary/metric reports for Management Review meetings

Ensure activities in Baxter Quality Plans are completed, identify opportunities, and craft action plans.

Job requirements

Education Level

Required:

Bachelor of Science or equivalent experience in IT/Computer Science or Bachelor of Applied Science/Engineering (Computer Software/Systems)

Major Subjects / Specialties

Required:

Science (Chemistry, Microbiology, Pharmacy, Engineering)

Type of Experience

Required:

Laboratory Equipment and Computer System/Software Validation experience

Manufacturing & Quality background

Previous experience in a GMP environment

Knowledge of GMP, ISO, and Regulatory standards

Preferred:

Knowledge of Corporate Quality requirements

Years of Experience

Required:

2 – 3 years of experience in a pharmaceutical environment

Preferred:

5+ years of successful experience in a pharmaceutical environment

Additional Skills / Special Training / Technical Skills Required

Required:

Strong understanding of Health Canada GMP and Medical Device Regulations

Detailed knowledge of applicable procedures, specifications, regulations, and standards

Strong process and project management capabilities

Strong written and oral communication skills, negotiation skills, and the ability to work with all levels of the organization

Ability to cultivate positive relationships with internal and external customers

Strong ability to balance multiple priorities

Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action

Strong analytical and problem-solving skills and critical thinking abilities

Intermediate to Advanced proficiency in Word, Excel, and PowerPoint

Solid understanding of statistical tools/techniques

Preferred:

PMP Courses or Certification

Ability to support our transformation to a LEAN enterprise through the application of LEAN tools

Proficiency in Trackwise System

Comprehension/Proficiency in Minitab

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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